BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHBR SLIDES

    MDR report key: 2880471 · Received December 19, 2012

    Report

    Report Number
    1319809-2012-00289
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    November 20, 2012
    Report Date
    December 19, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT UNEXPECTED VITROS PHBR QUALITY CONTROL RESULTS WERE OBTAINED ON A VITROS 5,1 FS CHEMISTRY SYSTEM. THE HIGHER THAN EXPECTED VITROS PHBR QUALITY CONTROL RESULTS WERE ASSOCIATED WITH AN ATYPICAL CALIBRATION CURVE, THE CAUSE OF WHICH IS UNKNOWN. FOLLOWING RECALIBRATION, IMPRECISE WITHIN-LAB VITROS PHBR QUALITY CONTROL PERFORMANCE HAS BEEN OBSERVED. IN PARTICULAR, THE LOWER THAN EXPECTED VITROS PHBR QUALITY CONTROL RESULTS WERE OBTAINED ON A SINGLE DATE, WITH NO CLEAR RESOLUTION YET ACHIEVED. RESULTS OF PRECISION TESTING DEMONSTRATED THAT THE VITROS 5,1 FS CHEMISTRY SYSTEM WAS PERFORMING AS EXPECTED AT THE TIME OF THE EVENT. THE CUSTOMER HAS BEEN SENT AN ALTERNATE LOT OF VITROS PHBR TO RUN FOR COMPARISON, AND THE INVESTIGATION IS ONGOING. THE INVESTIGATION TO DATE HAS NOT IDENTIFIED A DEFINITIVE ROOT CAUSE. HOWEVER, THE MOST LIKELY CAUSE OF THIS EVENT IS A REAGENT ISSUE RELATED TO VITROS PHBR LOT 2539-0062-2262. ADDITIONAL INVESTIGATION BY OCD REGARDING VITROS PHBR PERFORMANCE IS ONGOING.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED UNEXPECTED VITROS PHBR QUALITY CONTROL RESULTS ON A VITROS 5,1 FS CHEMISTRY SYSTEM. HIGHER THAN EXPECTED VITROS PHBR RESULTS OF 70.07, 71.35, 69.81, 69.82, 69.71, 71.73, 70.25, AND 70.29 NG/ML WERE OBTAINED FROM THE VITROS TDM PV III CONTROL FLUID VERSUS THE EXPECTED VALUE OF 58.08 NG/ML. ON A LATER DATE, LOWER THAN EXPECTED VITROS PHBR RESULTS OF 19.70 AND 20.17 NG/ML WERE OBTAINED FROM THE VITROS TDM PV II CONTROL FLUID VERSUS THE EXPECTED VALUE OF 26.84 NG/ML AND LOWER THAN EXPECTED VITROS PHBR RESULTS OF 43.82 AND 45.75 NG/ML WERE OBTAINED FROM THE VITROS TDM PV III CONTROL FLUID VERSUS THE EXPECTED VALUE OF 58.08 NG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. NO PATIENT SAMPLES WERE RUN FOR VITROS PHBR WHILE QUALITY CONTROL RESULTS WERE OUT OF RANGE. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER FIVE OF TWELVE MDR'S FOR THIS EVENT. TWELVE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWELVE DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS PHBR SLIDES IN-VITRO DIAGNOSTIC DLZ ORTHO-CLINICAL DIAGNOSTICS 2539-0062-2262

    Patients

    Seq Age Sex Outcome Treatment
    1